Site Name: USA - Maryland - Rockville
Posted Date: Oct
Are you interested in a highly-visible US regulatory affairs role that allows you to drive strategy and shape integrated regulatory development across portfolios? If so, this Regulatory Affairs Management Manager could be an ideal opportunity to explore.
As an Associate Director, you will ensure the development of appropriate US related regulatory strategy(s) and their execution for GSK's seasonal and pandemic Flu portfolio consistent with Medicines Development Strategy / Integrated Asset plan / Commercial strategy to ensure the development program and/or lifecycle plan meets the needs of the US market and the Medicines Profile. This goal has to be achieved while ensuring compliance with both internal GSK processes / policies and with appropriate regulatory requirements to deliver the best possible labeling to meet the Medicine Profile, commensurate with the available data.
Accountable to Global Regulatory Lead (GRL) for development of appropriate US regulatory strategy(s) and for delivery according to plans. In conducting the role, planning will be on a multiple year horizon, with delivery requiring extensive matrix working within GSK up to VP level and representing GSK with the US FDA. Work with the Vaccine Development Team (VDT) / Commercial organization, Global Industrial Operations and the GRL, to ensure a robust regulatory strategy is in place to support the development / post-approval life cycle program to meet the needs of the US market as described in the Medicine Profile / Integrated Asset plan / Lifecycle plan. Work closely with local commercial team to secure best possible labeling commensurate with the available data. Lead interactions with US regulatory authorities.
- Proactively develop US regulatory strategy, taking into account the needs of other regions globally.
- Implement the US strategy(s) in support of the project globally.
- Lead US regulatory interactions and the review local processes.
- Ensure appropriate interaction with global/US counterparts and commercial teams.
- Ensure compliance with global/US requirements at all stages of product life.
- Ideally assess precedent, regulatory intelligence and competitive environment from a regulatory perspective for the US and the impact this will have on the regulatory strategy for an asset.
- Ability to foster strong matrix working. Facilitates dialogue between team and matrix members to contribute their ideas. Capable of developing and recommending strategies for change.
- Shows a constant focus on improving performance and excellence in all tasks. Challenges and questions ways of working to seek improved process. Seeks to raise levels of performance by establishing or improving process.
- Good communication skills, especially in writing. Capable of delivering key communications with clarity, impact and passion.
- Ideally good listening and comprehension skills; proactive in identifying potential issues and escalating them accordingly.
- Capable of identifying project or team issues in advance and seeking necessary help and support to resolve.
- Ability to derive creative solutions to regulatory problems, while balancing the expectations of Agencies and ensuring compliance with regulation in all regions. Recognizes potential long-term issues for projects.
- Ability to make sound decisions and in doing so, the job holder will use a range of sources and weigh benefits and risks before making important decisions.
- Developing personal networks, within GSK and capable of using them to secure appropriate support and outcome for a project.
- Proficient in digital fluency capabilities to enhance project delivery and drive efficiency and innovation.
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- 8+ years of experience of all phases of the drug development process in regulatory affairs preferred.
- Capable of leading development, submission and approval activities in the US.
- Experience with clinical trial and licensing requirements in the US knowledge of other key Agency processes globally.
- Experience in relevant therapy area, and ability to further develop necessary specialist knowledge for the product or area of medicine.
The annual base salary for new hires in this position ranges from $128,350 to $173,650 taking into account a number of factors including work location within the US market, the candidate's skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.
Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1- (US Toll Free) or +1 (outside US).
GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
